NCT04008225

Brief Summary

Firstly, the study assesses the effect of bronchoalveolar lavage fluid (BAL) from patients in (acute respiratory distress syndrome (ARDS) on the life span of PNNs and on the phagocytosis of apoptotic cells by macrophages and polynuclear neutrophil (PNN). Then, the effect of an antibody directed against "high-mobility group box 1" protein (HMGB1) and the effect of metformin on efferocytosis are studied.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2016

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

July 2, 2019

Last Update Submit

July 4, 2019

Conditions

ARDS, Human

Keywords

Bronchoalveolar lavage

Outcome Measures

Primary Outcomes (1)

  • Lifespan of the PNNs

    The lifespan of the PNNs is an indicator of apoptosis : two groups are compared with and without incubation in BAL fluid. Neutrophil necrosis was assessed by flow cytometry using a phycoerythrin-conjugated active caspase-3 apoptosis kit (Becton Dickinson, USA)

    24 hours after BAL

Secondary Outcomes (4)

  • PNNs phagocytic index

    24 hours after BAL

  • Efferocytosis index

    24 hours after BAL

  • Increase of PNNs phagocytic index with HMGB1 activator

    24 hours after BAL

  • Increase of Efferocytosis index metformin

    24 hours after BAL

Study Arms (2)

ARDS group

Inpatients hospitalized in medical intensive care with a table of ARDS defined according to the Berlin criteria and requiring an BAL for a diagnostic purpose under a suspicion of pneumopathy acquired under mechanical ventilation.

Procedure: Bronchoalveolar lavage

Control group

The control group will be made up of patients with an BAL considered normal (endoscopy patients from the pneumology department). The normality of the BAL is defined by a normocellular wash with cellularity: \< 150,000 to 200,000 cells/mL Cell composition (formula): macrophages: 80-90%, lymphocytes 5 to 10% (\< 20%), neutrophils: \< 5%, eosinophils: \< 2%.

Procedure: Bronchoalveolar lavage

Interventions

Bronchoalveolar lavagePROCEDURE
ARDS groupControl group

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* ARDS Group : Inpatients hospitalized in medical intensive care with an ARDS defined according to the Berlin criteria and requiring an BAL(for diagnostic purpose in suspicion of pneumopathy acquired under mechanical ventilation). * Control group : The control population is made up with patients with a BAL considered normal (endoscopy patients from the pneumology department). The normality of the BAL is defined by a normocellular wash with cellularity: \< 150,000 to 200,000 cells/mL Cell composition (formula): macrophages: 80-90%, lymphocytes 5 to 10% (\< 20%), neutrophils: \< 5%, eosinophils: \< 2%.

You may qualify if:

  • ARDS Group : Inpatients hospitalized in medical intensive care with an ARDS defined according to the Berlin criteria and requiring an BAL(for diagnostic purpose in suspicion of pneumopathy acquired under mechanical ventilation).
  • Control group : The control population is made up with patients with a BAL considered normal (endoscopy patients from the pneumology department). The normality of the BAL is defined by a normocellular wash with cellularity: \< 150,000 to 200,000 cells/mL Cell composition (formula): macrophages: 80-90%, lymphocytes 5 to 10% (\< 20%), neutrophils: \< 5%, eosinophils: \< 2%.

You may not qualify if:

  • Age \< 18 years;
  • Pregnant women ;
  • Persons deprived of their liberty by judicial or administrative decision;
  • Persons legally incapable;
  • Persons not affiliated to a social security system;
  • Previously immunocompromised patients (HIV infection, hematopathy, organ transplantation, immunosuppression);
  • Patients who do not require a lung sample.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Rennes

Rennes, 35033, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Bronchoalveolar Lavage

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Therapeutic IrrigationInvestigative Techniques

Study Officials

  • Jean-Marc TADIE, MD, PhD

    University Hospital of Rennes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2019

First Posted

July 5, 2019

Study Start

May 5, 2015

Primary Completion

May 5, 2016

Study Completion

May 5, 2016

Last Updated

July 8, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)